Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin: Read across from Sarolaner API


A skin sensitization study was conducted on 3 groups of 5 female mice to determine if test item possesses a significant potential to cause skin sensitization according to OECD 429. 


The test item produced a stimulation index of < 3 in all groups of Test animals, and is not therefore considered a sensitizer (defined as producing a positive response).


 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across based on structural similarity
Justification for type of information:
Read across from Sarolaner API
Reason / purpose for cross-reference:
read-across source
Parameter:
SI
Value:
2.5
Test group / Remarks:
tested at concentration of 2.5%
Parameter:
SI
Value:
2.3
Test group / Remarks:
tested at concentration of 1%
Parameter:
SI
Value:
1.2
Test group / Remarks:
tested at concentration of 0.5%
Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced a stimulation index of < 3 in all groups of Test animals, and is not therefore considered a sensitizer (defined as producing a positive response).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:
in vivo: LLNA, Read across from Sarolaner API, SI < 3, not sensitising


Respiratory sensitisation:
No data available, not minimum required data.


Classification:
Skin: The stimulation indexes were below 3 in all tested concentrations in the murine local lymph node assay (OECD 429). Based on criteria in Table 3.4.2 of Regulation (EC) 1272/2008 and amendments, the substance does not have to be classified as a skin sensitiser.